FDA 510(k)

Shoulder Innovations Total Shoulder System

N.º K: K213615 · 2022-03-11

Fecha de decisión2022-03-11

Código de productoPKC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Shoulder Innovations Total Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K213615. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K213615.

When did Shoulder Innovations Total Shoulder System receive FDA 510(k) clearance?

Shoulder Innovations Total Shoulder System received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213615.

Who is the listed applicant for Shoulder Innovations Total Shoulder System?

The FDA 510(k) record lists Shoulder Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shoulder Innovations Total Shoulder System?

The FDA product code for Shoulder Innovations Total Shoulder System is PKC.

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Otros registros que enlistan a Shoulder Innovations, Inc. como solicitante

K262173N22 Offset Humeral Head K254128InSet Reverse Total Shoulder System K252516N22 EZ Glenosphere K252221Inset Reverse Total Shoulder System K241817InSet Total Shoulder System K210533Inset Reverse Total Shoulder System

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: PKC)

K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129Prótesis Humeral Sin Cuello AETOS Shoulder SystemSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716Prótesis Humeral Sin Cuello AETOS Shoulder SystemSmith & Nephew, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.